Virtual Reality Alcohol Avoidance Training

Not Applicable

• Conditions: Alcohol Use Disorder
• Interventions: Other: Computer-based approach avoidance training; Other: Virtual reality approach avoidance training

• Registration Number: NCT04283305
• Lead Sponsor: Universitätsklinikum Hamburg-Eppendorf

Brief Summary

The approach-avoidance training program (AATP) has shown preliminary promise as an add-on to standard treatment for alcohol dependence. However, knowledge is lacking as to whether the effectiveness of AATP can be enhanced further when performed in a typical drinking situation. The main aim of this study is to investigate whether approach-avoidance training implemented in a virtual reality bar environment is superior to the classical joystick PC-version of the AATP.

Detailed Description

The study will be implemented as a randomized controlled trial. A total of 135 consecutively enrolled alcohol use disorder (AUD) patients, recruited from alcohol inpatient clinics in Germany, Poland and Denmark, will be randomized into one of three groups at the start of standard alcohol treatment: group A) stimuli-relevant AATP as usual; group B) stimuli-relevant ATTP in virtual reality, and group C) treatment as usual (TAU; control group). Treatment outcomes will be assessed at pre-treatment, post-treatment and 3-month follow-up. Generalized mixed-models will be applied to compare the trajectories of the groups over time on drinking, craving and impulsiveness outcomes.

Study Timeline

• Status Verified: 2020-02
• Study First Submitted: 2020-02-14
• Study First Submitted QC: 2020-02-22
• Last Update Submitted: 2020-02-22
• Study First Posted: 2020-02-25
• Last Update Posted: 2020-02-25
• Study Start: 2020-03-01
• Primary Completion: 2020-12-31
• Study Completion: 2021-07-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 135

Inclusion Criteria

• signed written informed consent
• meeting the diagnostic criteria for alcohol use disorder
• fluent in language of the participating country (German, Polish or Danish)
• completion of detoxification (if needed)
• enrolled in standard treatment within two weeks

Exclusion Criteria

• any sensory or motor deficits complicating the provision of the AAT (e.g. color-blindness, fine or gross motor deficits in upper extremities)
• meeting diagnostic criteria for other substance use disorders
• severe psychiatric or neurological illness (e.g. psychotic disorders, mental retardation, dementia) or terminal somatic illness

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Computer-based approach avoidance training	Computer-based approach avoidance training	Participants will receive six sessions (three sessions per week for two weeks; session duration = 30 mins) of approach-avoidance training on the computer. Alcoholic beverages are pushed away with a joystick and soft-drinks will be pulled towards oneself. Training will begin approximately three weeks before discharge from the inpatient clinics to measure the add-on effect and to ensure that the add-on treatment does not extend the treatment period.
Virtual reality approach avoidance training	Virtual reality approach avoidance training	Participants will receive six sessions (three sessions per week for two weeks; session duration = 30 mins) of approach-avoidance training in the virtual reality. Alcoholic beverages are pushed away with a controller and soft-drinks will be pulled towards oneself. Training will begin approximately three weeks before discharge from the inpatient clinics to measure the add-on effect and to ensure that the add-on treatment does not extend the treatment period.

Primary Outcome Measures

Name	Time	Method
Changes in alcohol consumption	at baseline (day 0), at post-test (right after 14 days training period) and at follow up (84 days after post-test)	Alcohol consumption measures will be derived from the Timeline Followback (TLFB). The TLFB method involves using a calendar to identify alcohol consumption patterns in terms of number of drinks per day during the last 30 days. One drink is defined as 12 grams of ethanol. The Visual Analogue Scale (VAS) comprises single items used to measure the degree of alcohol cravings on scales ranging from 0-100, with 0 representing no cravings and 100 an extreme degree of cravings. The scale is presented visually on a ruler, and the individual will be requested to report the frequency, mean level and the peak level of cravings experienced during the last 30 days.

Secondary Outcome Measures

Name	Time	Method
Changes in alcohol abstinence self-efficacy	at baseline (day 0), at post-test (right after 14 days training period) and at follow up (84 days after post-test)	The 40-item Alcohol Abstinence Self-Efficacy Scale (AASE) measures current level of temptation to drink alcohol and self-efficacy to abstain from drinking. The scale applies 20 situations representing typical drinking cues. Twenty items pertain to temptation levels, the other 20 items to self-efficacy. Items are rated on scales ranging from not at all (0) to extremely (4). The measure comprises the following sub-scales: (1) negative affect; (2) social interaction and positive states; (3) physical and other concerns; and (4) withdrawal and urges (40).
Changes in impulsivity	at baseline (day 0), at post-test (right after 14 days training period) and at follow up (84 days after post-test)	The 30-item Barratt impulsiveness scale (BIS, Patton, Stanford, \& Barratt, 1995) assesses dimensions of impulsivity using three subscales: (1) attentional (attention and cognitive instability), (2) motor (motor and perseverance); and (3) non-planning (self-control and cognitive complexity). Items are rated on 4-point Likert scales ranging from 1 = very true for me to 4 = very false for me.
Changes in depression severity	at baseline (day 0), at post-test (right after 14 days training period) and at follow up (84 days after post-test)	The Beck Depression Inventory-II (BDI-II; Beck et a., 1996) is a 21-item multiple-choice instrument that measures the severity of depression. Each item is rated on a 4-point scale ranging from 0 to 3 based on severity.
Changes in alcohol-related craving	at baseline (day 0), at post-test (right after 14 days training period) and at follow up (84 days after post-test)	The 14-item obsessive-compulsive drinking scale (OCDS) measures the degree of cravings experienced during the last seven days. Items are rated on scales ranging from 0 to 4. The higher the score, the more pronounced the cravings. The scale has two subscales: obsessive cravings score and compulsive cravings score. A total score is calculated based on these subscales, and it is possible to calculate a resistance/impairment and interference subscale score.